1、 IEC 61676Edition 1.1 2009-01INTERNATIONAL STANDARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC61676:2002+A1:2008 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights res
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9、ARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology INTERNATIONAL ELECTROTECHNICAL COMMISSION CGICS 11.040.50; 11.040.55 PRICE CODEISBN 2-8318-1024-4 Registered trademark of the International Electrotechnical Commiss
10、ion 2 61676 IEC:2002+A1:2008(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope and object6 2 Normative references .6 3 Terminology and definitions7 4 General performance requirements for measurement of PRACTICAL PEAK VOLTAGE measurements10 4.1 Quantity to be measured .10 4.2 Limits of PERFORMANCE CHARAC
11、TERISTICs .10 4.3 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES.13 4.4 Performance test procedures.15 5 Special instrumental requirements and marking22 5.1 Requirements for the complete instruments.22 5.2 General .22 5.3 Display22 5.4 Range of measurement .22 5.5 Connectors and cables22 6
12、ACCOMPANYING DOCUMENTS.23 6.1 General .23 6.2 Information provided23 6.3 Instrument description .23 6.4 Detector 23 6.5 Delay time.23 6.6 Measurement window23 6.7 Data outlet 23 6.8 Transport and storage .23 Annex A (informative) Recommended performance criteria for the invasive divider 24 Annex B (
13、informative) Additional information on PRACTICAL PEAK VOLTAGE 25 Annex C (informative) Glossary of defined terms .32 61676 IEC:2002+A1:2008 (E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION MEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in d
14、iagnostic radiology FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning st
15、andardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their prepar
16、ation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely wi
17、th the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant sub
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20、possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any e
21、quipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees an
22、d IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) A
23、ttention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights
24、 IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 61676 has been prepared by subcommittee SC 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62: Electrical equipment in medical practice.
25、 This consolidated version of IEC 61676 consists of the first edition (2002) documents 62C/340/FDIS and 62C/344/RVD and its amendment 1 (2008) documents 62C/445/CDV and 62C/452/RVC. The technical content is therefore identical to the base edition and its amendment and has been prepared for user conv
26、enience. It bears the edition number 1.1. A vertical line in the margin shows where the base publication has been modified by amendment 1. NOTE In the amendment, a new influence quantity “Additional tungsten filtration (tube aging)” has been introduced. 4 61676 IEC:2002+A1:2008(E) Annexes A, B and C
27、 are for information only. In this standard the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; notes, explanations, advice, general statements and exceptions: in small roman type; test specifications: in italic type; TERMS USED THRO
28、UGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 OR IN IEC 60601-1 AND ITS COLLATERAL STANDARDS: IN SMALL CAPITALS. The committee has decided that the contents of the base publication and its amendments will remain unchanged until the maintenance result date indicated on the IEC web site unde
29、r “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. NOTE The committee is aware of the fact that this
30、 standard does not address all problems associated with non-invasive high voltage measurements. In particular one influence quantity concerning the target condition is not dealt with at all. Before this can be done, a substantial amount of measurements is still necessary to improve the physical unde
31、rstanding of this influence quantity. On the other hand, for the reasons described in the introduction there is an urgent need to publish this standard in order to assure that non-invasive measurements are comparable to each other within tolerable uncertainties, regardless of differences in X-RAY GE
32、NERATOR, waveform or other influence quantities (except target condition), which is not the case for the time being. The committee has decided to revise this standard as soon as sufficient knowledge on the outstanding items is available. 61676 IEC:2002+A1:2008 (E) 5 INTRODUCTION The result of a meas
33、urement of the X-RAY TUBE VOLTAGE by means of invasive or non-invasive instruments is normally expressed in the form of one single number for the value of the tube voltage, irrespective of whether the tube voltage is constant potential or shows a time dependent waveform. Non-invasive instruments for
34、 the measurement of the X-RAY TUBE VOLTAGE on the market usually indicate the mean peak voltage. But the quantity mean peak voltage is not unambiguously defined and may be any mean of all voltage peaks. It is impossible to establish test procedures for the performance requirements of non-invasive in
35、struments for the measurement of the X-RAY TUBE VOLTAGE without the definition of the quantity under consideration. Therefore, this Standard is based on a quantity recently proposed in the literature1to be called “PRACTICAL PEAK VOLTAGE“. The PRACTICAL PEAK VOLTAGE is unambiguously defined and appli
36、cable to any waveform. This quantity is related to the spectral distribution of the emitted X-RADIATION and the image properties. X-RAY GENERATORS operating at the same value of the PRACTICAL PEAK VOLTAGE will produce the same low level contrast in the RADIOGRAMS, even when the waveforms of the tube
37、 voltages are different. Detailed information on this concept is provided in Annex B. An example for the calculation of the PRACTICAL PEAK VOLTAGE in the case of a “falling load” waveform is also given in Annex B. As a result of introducing a new quantity, the problem arises that this standard has b
38、een written for instruments which were not explicitly designed for the measurement of the PRACTICAL PEAK VOLTAGE. However, from preliminary results of a trial type test of a non-invasive instrument currently on the market, it can be expected that future instruments and most instruments on the market
39、 will be able to fulfil the requirements stated in this standard without insurmountable difficulties. For the most critical requirements on voltage waveform and frequency dependence of the RESPONSE, it turned out from these investigations that it is even easier to comply with the standard by using t
40、he PRACTICAL PEAK VOLTAGE as the measurement quantity. The calibration and adjustment of the X-RAY TUBE VOLTAGE of an X-RAY GENERATOR is generally performed by the MANUFACTURER using a direct INVASIVE MEASUREMENT. Instruments utilising NON-INVASIVE MEASUREMENTS can also be used to check the calibrat
41、ion or to adjust THE X-RAY TUBE VOLTAGE. These instruments are required to have uncertainties of the voltage measurement comparable with the INVASIVE MEASUREMENT. One of the most important parameters of diagnostic X-RAY EQUIPMENT is the voltage applied to the X-RAY TUBE, because both the image quali
42、ty in diagnostic radiology and the DOSE received by the PATIENT undergoing radiological examinations are dependent on the X-RAY TUBE VOLTAGE. An overall uncertainty below 5 % is required, and this value serves as a guide for the LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES. 1See annex
43、 B. 6 61676 IEC:2002+A1:2008(E) MEDICAL ELECTRICAL EQUIPMENT Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology 1 Scope and object This International Standard specifies the performance requirements of instruments as used in the NON-INVASIVE MEASURE
44、MENT of X-RAY TUBE VOLTAGE up to 150 kV and the relevant compliance tests. This standard also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement a
45、re found in diagnostic RADIOLOGY including mammography, COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY. This standard is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. 2 Normative references T
46、he following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60417 (all parts), Graphical symbols for use o
47、n equipment IEC 60788:1984, Medical radiology Terminology IEC 61000-4-2:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 2: Electrostatic discharge immunity test. Basic EMC Publication IEC 61000-4-3:2000, Electromagnetic compatibility (EMC) Part 4-3: Testi
48、ng and measure-ment techniques Radiated, radio-frequency, electromagnetic field immunity test. Basic EMC Publication IEC 61000-4-4:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication IEC
49、61000-4-5:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 5: Surge immunity test. Basic EMC Publication IEC 61000-4-6:1996, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 6: Immunity to conducted disturbances, induced by radio frequency fields. Basic EMC Publication IEC 61000-4-11:1994, Electromagnetic compatibility (EMC) Part 4: Testing and measure-ment techniques Section 11: Voltag
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